Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Supragingival Control Versus Supra- and Subgingival Control in the Periodontal Health During the Maintenance

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sabrina Carvalho Gomes, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01598155
First received: May 10, 2012
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

Seventy patients will be previously treated for moderate-to-severe periodontitis according to their individual needs. Thirty days after completion of periodontal treatment, these patients will be randomized to one of the following groups of periodic preventive maintenance (PPM): G1 - performed only control supragingival; G2 - performed supra and subgingival control (when necessary).

The maintenance consultations will be scheduled every 3 months for 24 months. The hypothesis is that the effect of the supragingival control (conducted over 24 months) will be similar to the effect of the supra- and subgingival control combined, above the restoration and progression of periodontitis.


Condition Intervention
Periodontitis
Procedure: Group 1 - Supragingival biofilm control
Procedure: Group 2 - Supra- and subgingival biofilm control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Supragingival Biofilm Control, and the Combination of Supra and Subgingival Biofilm Control in Periodontal Health of Patients Participating in a Periodontal Preventive Maintenance Program - A Randomized Clinical Trial.

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Mean Attachment Loss (AL) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.


Secondary Outcome Measures:
  • Periodontal Probing Depth (PPD) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    PPD: defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.

  • Microbiological markers [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To assess the prevalence of P gingivalis, P micra and D pneumosintis on the subgingival plaque samples


Estimated Enrollment: 70
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supragingival biofilm control Procedure: Group 1 - Supragingival biofilm control

30 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months):

  • Scaling, planning and polishing coronary surface;
  • Education and motivation for oral hygiene and daily supragingival biofilm control by the patient.
Other Name: G1
Experimental: Supra- and subgingival biofilm control Procedure: Group 2 - Supra- and subgingival biofilm control

30 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months):

  • Scaling, planning and polishing of coronary surface;
  • Education and motivation for oral hygiene and daily supragingival biofilm control by the patient;
  • Subgingival scaling and root planning in sites with persistent bleeding on probing and probing depth unchanged.
Other Name: G2

Detailed Description:

This randomized clinical trial, single-blind, aims to compare the effect of the supragingival biofilm control with the effect of supra- and subgingival biofilm control, performed by the patient-professional binomial, in periodontal patients treated, above the restoration and progression of periodontitis during the preventive periodic maintenance (PPM). Seventy patients with moderate-to-severe periodontitis, aged from 35 years, will be included. Participants will be periodontally treated according to their needs. After 30 days of the end of treatment, participants will be randomized (stratified for smoking) in two groups: Group 1 (G1)- Supragingival biofilm control; Group 2 (G2)- Supra and subgingival biofilm control. MPP consultation will take place every 3 months, for 24 months, in which the G1 will only receive procedures of supragingival biofilm control, and G2 will receive, beyond the supragingival control, subgingival interventions.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age from 35 years;
  • present at least 12 teeth in the mouth;
  • patients diagnosed with moderate-to-severe periodontitis according to the criteria of the AAP (1999):

    • to present ≥ 2 interproximal sites with AL ≥ 6 mm AND ≥1 interproximal site with PD ≥ 5 mm; or
    • to present ≥ 2 interproximal sites with AL ≥ 3mm OR ≥ 2 interproximal sites with PD ≥ 5 mm (in different teeth).

Exclusion Criteria:

  • presence of systemic conditions unfavorable to periodontal treatment (diabetes, cardiovascular changes with antimicrobial prophylaxis indicated);
  • positive history of periodontal treatment and maintenance in the 12 months preceding the study;
  • positive history of using anti-inflammatory drugs and antibiotics in the 3 months prior to initial consultation;
  • patients in use of fixed orthodontic appliance;
  • pregnant patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598155

Locations
Brazil
School of Dentistry, Federal University of Rio Grande do Sul
Porto Alegre, RS, Brazil, 90035-003
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
Principal Investigator: Sabrina Carvalho Gomes, DDS, PhD Federal University of Rio Grande do Sul
  More Information

No publications provided

Responsible Party: Sabrina Carvalho Gomes, DDS, PhD, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01598155     History of Changes
Other Study ID Numbers: SGomes 01
Study First Received: May 10, 2012
Last Updated: November 11, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
dental biofilm
periodontitis
maintenance
randomized clinical trial
biomarkers
bacterias
gingival crevicular fluid

Additional relevant MeSH terms:
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 27, 2014